1. What measurement system capabilities do medical device manufacturers need that are different from other manufacturing fields?
Medical manufacturers expect more relative to process control, access, and compliance. ZONE3 workflow on a QVI system enables control of different types of user’s access, certain types of part runs, program edits, failure mode assistance, and corrective action definition. Managers can also approve/adjust validated programs and approve inspections results. The medical industry is all about traceability, documenting all activities throughout a device’s life cycle. Our equipment meets medical device compliance standards needed to comply to FDA requirements.
2. What products/services does QVI offer to help manufacturers meet these stringent requirements?
The medical industry is 30% to 40% of our business, so we understand how manufacturers implement our equipment and we have developed products, software, and services to support this. MultiSensor Metrology Systems and sensors address specific medical device metrology challenges, and we provide documentation services for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Most important, we tailored our ZONE3 Metrology software to address medical device needs.
3. How does a day in the life of a medical device manufacturer using QVI products play out?
Let’s take heart valves and orthopedic implants, high-risk devices. Employees may use a biometric scanner – fingerprint or retina – to determine what level access they have. A manufacturing operator may only be allowed to initiate certain inspection routines, while a higher-level technician, engineer, or manager could access higher-risk part inspections, modifications, or approvals.
Next, the user loads a part, the system displays an image of the part, and the user initiates inspection. A secure and validated program is loaded and can be executed completely as a first article inspection, partially, or for only critical dimensions – the key being that it is only one program – i.e., one validation, with different scenarios of execution in ZONE3.
A pass/fail report is generated with visual representation of problem areas – color deviation report, along with any assignable causes and corrective actions the operator or manager indicates.
For traceability, data is seamlessly dropped into the digital thread of the product lifecycle as part of Industry 4.0.
4. What is the medical community expecting from Industry 4.0?
One big aspect of Industry 4.0 is the support of model-based definition (MBD) and support of product manufacturing information (PMI). ZONE3 supports importing a CAD model with PMI information, simplifying the programming process because it tells the machine a lot about the part that users typically enter manually. This enables efficient programming, quick adoption of new parts, and recommendations for how to improve the manufacturing process. QVI Evolve Suite from our Kotem division delivers design to manufacturing feedback.
5. What sets QVI apart when it comes to medical device quality assurance?
Multisensing! We have focused on the MultiSensor systems since 1986. Manufactured parts continued to get more complex, requiring more than one type of data acquisition to quickly, accurately, and completely measure a part. The SmartScope, and more recently the Fusion and FlexPoint offer that capability.
Parts and tools that are made for the human body are not typical, prismatic elements. They contain curved surfaces, intricate details, and are related to high-risk user requirements. MultiSensor systems deliver maximized metrology capability and unprecedented accuracy, without compromising usability, access control, or uncertainty.